Standards

YY/T 1284-2024 Active

YY/T 1284-2024 Dentistry—Dental tweezers

This document specifies the general requirements for dental forceps and describes the corresponding test methods.
This document is applicable to single-curved and double-curved metal dental forceps.
This document is not applicable to dissection forceps and medical forceps.

Publish Date: 2024-09-29

YY/T 1233-2024 Active

YY/T 1233-2024 Cardiac troponin detection reagent kit(labelling immunoassay)

This document specifies the requirements for myocardial troponin assay kits (labeled immunoassay), including identification, labeling, and user manuals, as well as packaging, transportation, and storage, and describes the corresponding test methods.
This document is applicable to kits used for the quantitative detection of myocardial troponin I (hereinafter referred to as cTnI) and myocardial troponin T (hereinafter referred to as cTnT) in human serum, plasma, or whole blood in vitro. The methods include enzyme-linked immunosorbent assay (ELISA), enzymatic and non-enzymatic chemiluminescence, electrochemiluminescence, and time-resolved fluorescence immunoassay, etc.

Publish Date: 2024-09-29

YY/T 1183-2024 Active

YY/T 1183-2024 Detection reagent kit for enzyme-linked immunoabsorbent assay

This document specifies the requirements, marking, labeling, and usage instructions for enzyme-linked immunosorbent assay (ELISA) test kits, as well as their packaging, transportation, and storage. It also describes the corresponding testing methods.
This document applies to quantitative or qualitative detection kits (hereinafter referred to as "test kits") that use ELISA as the principle for testing in medical laboratories.

Publish Date: 2024-09-29

YY/T 0866-2024 Active

YY/T 0866-2024 Total inward leakage(TIL) determination method of protective face mask for medical use

This document describes the test method for the total leakage rate of medical protective masks. This document is applicable to the evaluation of the total leakage rate of medical protective masks (hereinafter referred to as masks). For the evaluation of the leakage rate of other medical biological protective devices, this document can be used as a reference.

Publish Date: 2024-09-29

YY/T 0860-2024 Active

YY/T 0860-2024 Radio frequency ablation instrument for cardiac application

This document specifies the classification and requirements of cardiac radiofrequency ablation therapy equipment (hereinafter referred to as the equipment) and its accessories, and describes the corresponding test methods.
This document applies to cardiac radiofrequency ablation therapy equipment and its accessories. This type of equipment is used in cardiac interventional radiofrequency ablation surgery or cardiac/thoracic surgery radiofrequency ablation surgery.

Publish Date: 2024-09-29

YY/T 0802.2-2024 Active

YY/T 0802.2-2024 Processing of medical device—Information to be provided by the medical device manufacturer—Part 2:Non-critical medical devices

This document specifies the requirements for the information provided by medical device manufacturers regarding the handling of low-risk medical devices (i.e., medical devices that only come into contact with intact skin or medical devices that do not directly contact patients).
This document applies to the information required for handling medical devices before they are used or reused.

Publish Date: 2024-09-29

YY/T 0802.1-2024 Active

YY/T 0802.1-2024 Processing of medical devive—Information to be provided by the medical device manufacturer—Part 1:Critical and semi-critical medical devices

This document specifies the requirements for the information provided by medical device manufacturers regarding the handling of highly dangerous medical devices (i.e., medical devices that enter the normal sterile parts of the human body, or medical devices that come into contact with mucous membranes or incomplete skin) or medical devices prepared for sterilization.
This document applies to the information provided for the handling of medical devices before they are used or reused.

Publish Date: 2024-09-29

YY/T 0787-2024 Active

YY/T 0787-2024 Ophthalmic instruments—Corneal topographers

This document specifies the minimum requirements for corneal topography instruments and systems, the accompanying documents and markings, and describes the corresponding testing methods.
This document applies to instruments or systems used to measure the surface shape of the human eye's cornea.
Note: The measurement results may include the surface curvature of a localized area, the dimensions of the surface's three-dimensional topography, or other more comprehensive parameters used to characterize the surface features.
This document does not apply to corneal curvature meters in ophthalmic instruments.

Publish Date: 2024-09-29

YY/T 0688.2-2024 Active

YY/T 0688.2-2024 Clinical laboratory testing and in vitro diagnostic test systems—Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices—Part 2:Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution

This document establishes acceptable performance standards for antimicrobial susceptibility testing (AST) equipment. These devices are used in medical laboratories to determine the minimum inhibitory concentration (MIC) of bacteria to antimicrobial drugs.
This document specifies the requirements for AST equipment and the procedures for evaluating the performance of these devices. It provides guidance on how to conduct performance evaluations of AST equipment.
This document is applicable to guiding manufacturers in conducting performance evaluation studies.

Publish Date: 2024-09-29

YY/T 0581.2-2024 Active

YY/T 0581.2-2024 Infusion access adapter—Part 2:Needleless access adapters

This document specifies the requirements for single-use needle-free connectors (hereinafter referred to as connectors) and describes the corresponding test methods.
This document is applicable to self-sealing, single-use needle-free connectors used in non-puncture applications. Products supplied with connectors integrated into intravascular indwelling devices (such as intravenous indwelling needles) shall refer to and implement this document.
The anti-reflux valves specified in YY 0585.4 are not included in the scope of this document.
The switches specified in YY 0585.2 are not included in the scope of this document.

Publish Date: 2024-09-29

YY/T 0576-2024 Active

YY/T 0576-2024 Columbia blood agar medium

This document specifies the main components and preparation methods, requirements, marking, labeling, and usage instructions, packaging, transportation, and storage of Columbia blood agar media, and describes the corresponding testing methods.
This document is applicable to Columbia blood agar media, including dry powder media and plate media.

Publish Date: 2024-09-29

YY/T 0339-2024 Active

YY/T 0339-2024 Suction catheters for use in the respiratory tract

This document specifies the dimensions and requirements for respiratory suction catheters.
This document applies to open and closed suction catheters made of flexible materials intended for respiratory suction.
This document does not apply to suction catheters intended for use with flammable anesthetic gases or reagents, laser or electrosurgical equipment.

Publish Date: 2024-09-29